BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIO-SEAL

    MDR report key: 118605 · Received September 8, 1997

    Report

    Report Number
    3014398-1997-00107
    Event Type
    Malfunction
    Date Received
    September 8, 1997
    Date of Event
    August 6, 1997
    Report Date
    August 6, 1997
    Manufacturer
    QUINTON INSTRUMENT CO.
    Product Code
    MGB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A DIAGNOSTIC PROCEDURE, AN ANGIO-SEAL DEVICE WAS PLACED AND HEMOSTASIS WAS ACHIEVED. HOWEVER, ONE HR LATER, BLEEDING WAS NOTED. MANUAL PRESSURE WAS HELD FOR A DURATION OF 20 MINS, WHICH CONTROLLED THE BLEEDING WITHOUT DIFFICULTY. SUBSEQUENTLY A PRESSURE DRESSING WAS APPLIED. THE PT TOLERATED THE PROCEDURE WELL, AND WAS DISCHARGED HOME WITH NO SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIO-SEAL Implant HEMOSTATIC PUNCTURE CLOSURE DEVICE MGB QUINTON INSTRUMENT CO. NA 800562

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR